KCTL

Medical Equipment

Global Certification

Safety

MET
Biocompatibility
GMA

MET

MET is the first OSHA-recognized NRTL (Nationally Recognized Testing Laboratory) in the United States. NRTL certification provides clear evidence that your electrical and electronic products comply with the required standards of the North American market. The MET Mark clearly indicates compliance to US and Canadian requirements.

It helps access not only the North American market but also the global market through the global network of Eurofins Group. Eurofins global offers an overall solution to various regulations, including safety, EMC and energy efficiency testing.

Products

01 EV Charger
02 ATM Machine
03 Industrial Machine
04 Industrial Vacuum Pump
05 Industrial components
06 Household Equipment
07 AV/IT Product

SERVICE AREA

• Product Safety Certification for US-NRTL

• Canada SCC, and IECEE-CB Scheme, with testing and reporting for EU-CE

• On-site Field Evaluation, Labelling and LPC(Limited Production Certification)

• Reliability Reporting Service

• Medical test, Factory automation test,

• ATEX/IECex/HazLoc for explosion proof equipment(Europe, Asia and USA)

• Energy Efficiency Testing & Certification (USA)

• Telecom / NEBS Testing

• CE LVD, MD (Machinery Directive)

• Semiconductor machine for SEMI S2, S6, S8, S22, F47

SERVICE PROCESS

STEP 01

Application
STEP 02

Confirmation of document and prodcut
STEP 03

Progress test

STEP 04

Issue draft report
STEP 05

Initial inspection
STEP 06

Issue final report & certificate

CONTACT

Please contact us for more information.

Phone NO. 070-4652-4400
E-mail CKR011_met@cpt.eurofinsasia.com

Biocompatibility

Medical devices come into direct or indirect contact with the human body, so ensuring their safety is essential. Biocompatibility testing assesses any potential adverse effects the device may cause. Conducted in accordance with the ISO 10993 series, these evaluations scientifically confirm the safety and reliability of the product.

Eurofins provides comprehensive biocompatibility testing solutions for medical devices, grounded in extensive global testing capabilities and internationally accredited quality systems. We offer testing and evaluation services that fully comply with the requirements of leading global regulatory authorities, enabling us to serve as a reliable and authoritative partner in supporting our clients’ successful entry into international markets.

Products

01 Intact Skin
02 Intact Mucosal Membrane
03 Breached or Compromised (Skin or Mucosal Membrane)
or Internal tissue

SERVICE AREA

• ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

• ISO 10993-4: Selection of tests for interactions with blood

• ISO 10993-5: Tests for in vitro cytotoxicity

• ISO 10993-6: Tests for local effects after implantation

• ISO 10993-10: Tests for skin sensitization

• ISO 10993-11: Tests for systemic toxicity

• ISO 10993-23: Tests for irritation

• ISO 10993-17: Toxicological risk assessment of medical device constituents

• ISO 10993-18: Chemical characterization of medical device materials within a risk management process

• Biological Evaluation Plan and Report

SERVICE PROCESS

STEP 01

Application
STEP 02

Determination of Test Items
STEP 03

Review and Approval of Study Plan

STEP 04

Study Conduct
STEP 05

Issuance ofDraft Report
STEP 06

Issuance ofFinal Report

CONTACT

Please contact us for more information.

Phone NO. 070-4652-6546
E-mail CKR011_gma@cpt.eurofinsasia.com

GMA Global Market Access

The requirements for a given product are quite different around the world. A correct certification is required before a product is sold in the particular country.

Eurofins KCTL helps clients to obtain the required certifications and approvals for 200 countries.